drugset / Trial / NCT03912350

The Effect of Hepatic Impairment on the Pharmacokinetics of Balovaptan

NCT03912350

Phase 1 Withdrawn Hoffmann-La Roche
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a multi-center, non-randomized, open-label, parallel group, multiple-dose study to assess the pharmacokinetic, safety, and tolerability of balovaptan in male and female subjects with moderate hepatic impairment compared to healthy subjects with normal hepatic function matched by age (±10 years), sex, and body mass index (BMI; ±20%).

Timeline

Start
2022-06-26
Primary completion
2022-09-24
Completion
2022-10-13

Drugs

EvaluationDrugModalityDoseRoute
Subject Balovaptan Small molecule Oral